Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.39) announced that it has submitted a NDA for AEZS-130 for adult growth hormone deficiency (“AGHD”). ImmunoGen, Inc. (Nasdaq: IMGN $13.41) announced that it will discontinue their Phase 2 trail of IMGN901 for SCLC, following the recommendation from the Data Monitoring Committee (DMC) due to a higher rate of infection and […]

Dynavax Technologies Corporation (NASDAQ: DVAX) reported that following a meeting with the FDA regarding its Biologic License Application (BLA) for HEPLISAV,an adult hepatitis B vaccine, additional safety data would be required before they refile their BLA. This would most likely necessitate the need for a new trial. Clovis Oncology (NASDAQ:CLVS) announced that it has commenced an underwritten […]

Affymax, Inc. (NASDAQ:AFFY) announced in a filing that the contract of its CEO, John Orwin, has been terminated. This follows a company-wide restructuring plan by The Brenner Group, Inc, a restructuring firm assigned by Affymax. Rockwell Medical, Inc. (Nasdaq:RMTI) announced it intends to offer shares in an underwritten public offering. ACADIA Pharmaceuticals Inc. (ACAD) also announced it intends to offer shares […]

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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Dear readers of BioPharmCatalyst, Thank you to all readers who have followed and supported BioPharmCatalyst over the past five years. Yes, that’s correct, BioPharmCatalyst celebrated it’s 5th anniversary earlier this week. BPC is run independently and a change in working circumstances has meant that updating the website has become quite time consuming to maintain over the past […]

Latest updates to the Company Pipeline Database for May 18 and 19, 2015. Refer to the FDA Calendar for upcoming catalysts: In addition, over 100 updates were made over the weekend as companies continued with their reporting season. You can find the updates from last week by clicking the “updated” column on the far right of the Company Pipeline Database. […]